OncoMatch/Clinical Trials/NCT07265674
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer
Is NCT07265674 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Nanvuranlat for advanced biliary tract cancer.
Treatment: Nanvuranlat — This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: SLC7A5 expression testing required (testing required; no eligibility threshold specified)
Willing to participate in LAT1 testing
Required: NAT2 genotyping required
Willing to participate in...NAT2...genotyping
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (cisplatin, carboplatin, oxaliplatin) — advanced disease (locally advanced or metastatic)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (no myeloid growth factors within 7 days); Hemoglobin ≥ 8.5 g/dL (no RBC transfusions during 14 days before first dose); Platelet count ≥ 100 × 10^9/L (no platelet transfusions during 14 days before first dose)
Kidney function
eGFR ≥ 50 mL/min as estimated by CKD-EPI 2021
Liver function
Bilirubin ≤ 2 × ULN (local institution); AST and ALT ≤ 5 × ULN (local institution)
Cardiac function
QTcF ≤ 470 msec at screening
Adequate hematologic function: ANC ≥ 1.5 × 10^9/L...Hemoglobin ≥ 8.5 g/dL...Platelet count ≥ 100 × 10^9/L...Adequate baseline organ function: eGFR ≥ 50 mL/min...Bilirubin ≤ 2 × ULN...AST and ALT ≤ 5 × ULN...Resting QTcF > 470 msec at screening [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center (Site 106) · Gilbert, Arizona
- City of Hope (Site 107) · Duarte, California
- University of California at Irvine (Site 101) · Orange, California
- UCLA Medical Center (Site 117) · Santa Monica, California
- Norton Cancer Institute (Site 115) · Louisville, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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